An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome (NCT05066217)
Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients With Lennox-Gastaut Syndrome
🩺 Plain-English Summary (8th-Grade Level)
This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCL (EPX-100) as adjunctive therapy in children and adult participants with Lennox-Gastaut syndrome (LGS).
Who can join: Review the eligibility criteria below.
Location: Arkansas Children's Hospital — Little Rock, Arkansas
Age range: 2 Years to 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (55 Sites)
Showing the first 25 of 55 sites.
- Arkansas Children's Hospital — Little Rock, Arkansas
- UC Irvine Medical Center — Orange, California
- University of Miami Miller School of Medicine — Miami, Florida
- AdventHealth Innovation Tower — Orlando, Florida
- Rare Disease Research — Orlando, Florida
- Pediatric Neurology and Epilepsy Specialists — Winter Park, Florida
- Re:Cognition Health — Chicago, Illinois
- Norton Children's Medical Center — Louisville, Kentucky
- Henry Ford Hospital — Detroit, Michigan
- Minnesota Epilepsy Group, P.A. — Roseville, Minnesota
- Children's Nebraska — Omaha, Nebraska
- Tekton Research — Marlboro, New Jersey
- NYU Comprehensive Epilepsy Center - BRANY - PPDS — New York, New York
- Weill Cornell Medicine/New York Presbyterian Hospital — New York, New York
- Atrium Health STRIVE Research — Charlotte, North Carolina
- On-Site Clinical Solution — Charlotte, North Carolina
- Duke University Medical Center — Durham, North Carolina
- PPD Virtual-Science 37, Inc. — Morrisville, North Carolina
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- UTHealth Houston — Houston, Texas
- Clinical Neurosciences Center — Salt Lake City, Utah
- Peking University First Hospital - Changqiao Campus — Beijing,
- Peking University First Hospital - Daxing Campus — Beijing,
- Beijing Children's Hospital, Capital Medical University - PIN — Beijing,
- The First Hospital of Jilin University — Changchun,
📞 Contact the Study Coordinator
Phone: (302) 559-4320
Email: clinicaltrials@harmonybiosciences.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.